Clinical Project Associate

This is a fully remote position, open to applicants in Tennessee.

📋 Description

• Ensure that the Trial Master File (TMF) is established and maintained in a state that is ready for audits.

• Gather, upload, and conduct an initial quality assessment of TMF/eTMF documents.

• Collaborate with document specialists to sustain the TMF from the initiation to the conclusion of the study.

• Assist in verifying the qualifications of investigators and investigative sites throughout the clinical trial process.

• Distribute and gather essential documents from investigative sites during the entire clinical trial lifecycle.

• Coordinate with Clinical Research Associates and investigative sites to address any unresolved regulatory concerns.

• Review study documents to confirm they are up-to-date, complete, and accurate.

• Maintain clinical trial management systems and tracking tools effectively.

• Engage in cross-functional teams to ensure the timely delivery of project objectives.

• Execute other assigned responsibilities as needed.

⛳️ Requirements

• A minimum of a High School Diploma or GED is required.

• At least 1 year of experience in clinical research is necessary.

• Experience in oncology clinical research is preferred.

• A minimum of 3 years of clinical research experience is preferred.

• Familiarity with Good Clinical Practices, ICH Guidelines, Federal Regulations, and Development Innovations SOPs is required.

• Candidates must be located in the United States.

• Ability to maintain clinical trial management systems and tracking tools is essential.

• Competence in conducting TMF/eTMF documentation collection, review, and filing is required.

• Must be able to verify the qualifications of investigators and investigative sites.

🏝️ Benefits

• A comprehensive benefits package that supports physical, mental, and financial wellness.

• Opportunities for annual bonuses or long-term incentives may be provided.

• Relocation assistance is not offered.

• Visa sponsorship is not available.